NCT06698484招募中2 期
A Phase II Open Label Single-arm Study to Evaluate Safety and Efficacy of Autologous CD19 CAR-T Cells in Patients With Relapsed/Refractory B- Non-Hodgkin Lymphoma
National University of Malaysia1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2021年6月3日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Overall response rate (ORR)
研究概览
简要总结
A Phase II Open-Label Single-arm Study to Evaluate Safety and Efficacy of locally manufactured autologous CD19-directed CAR T-cells in Patients with Relapsed/Refractory B- Non-Hodgkin Lymphoma (B-NHL) or patients not eligible for hematopoietic stem cell transplantation (HCT)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with histologically confirmed diagnosed with CD19 positive B cell NHL in accordance with WHO classification
- •Patients who are refractory to second-line treatment or patients who relapsed after first-line treatment with no available curative options such as autologous or allogeneic haematopoietic stem cell transplantation (HSCT) or relapse within one year of autologous HSCT
- •At least one measurable lesion according to revised IWG response criteria
- •Age between ≥13to ≤75 years
- •Adequate organ function as defined by a creatinine clearance >40 ml/min, serum alanine transaminase (ALT) < 5 times the normal value, serum bilirubin < 3 times the normal value, left ventricular ejection fraction> 45%
- •Absolute neutrophil count ≥ 1500/μl, haemoglobin level ≥ 7 g/dl, platelets ≥ 50000/μl.
- •Life expectancy >12 weeks
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- •Female of childbearing age must have a negative pregnancy test and is on two effective contraception methods
- •Male patients must use two effective contraception methods
排除标准
- •Active central nervous system (CNS) lymphoma (detected by Imaging study or cerebrospinal fluid (CSF) analysis)
- •Active cancer(other than NHL) or receiving cancer treatment
- •Evidence of severe lung, heart (New York Heart Association class III/IV, arrhythmia, heart block, uncontrolled hypertension), liver, or renal failure or severe neurologic disorder
- •Presence of active autoimmune disease requiring immunosuppressive therapy
- •Human Immunodeficiency Virus (HIV) positivity
- •Active Hepatitis B, and Hepatitis C infection
- •Uncontrolled infection
- •Pregnant/nursing female.
- •Receiving autologous or allogeneic stem cell transplant within 12 weeks of enrolment
研究组 & 干预措施
Patient will infuse with autologous CD19 CAR-T cells
Experimental
CD19 CAR-T cells
干预措施: CAR-T cells (Drug)
结局指标
主要结局
Overall response rate (ORR)
时间窗: From day 30, then 3 monthly until 24 months after infusion of CAR-T cells
The ORR is the sum of patients achieving complete response (CR) and partial response (PR) at day 30, then 3 monthly up to 24 months after receiving CAR T-cells determined by the investigator following Lugano criteria in non-Hodgkin Lymphoma (NHL). Response assessment will be determined using a PET CT scan, or other relevant imaging studies and compared to the baseline (pre-CAR-T infusion) study.
次要结局
- overall survival(OS at day 30, 6 months and one year, and 2 years following CAR-T cells infusion)
- Incidence of adverse events(From the time of infusion up to 24 months after infusion of CAR-T cells)
研究者
研究点 (1)
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